My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.
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The noble Lord, Lord Sharkey, suggested in Committee and again during discussions in December that we would return to this issue of procedure, which he has now done through the amendments in this group. I am extremely grateful to him for the advance warning, although I have to say that our positions are at some distance.
Amendments 3, 28, 41 and 49 would apply the super-affirmative procedure to the regulation-making powers in Clauses 1, 9, 14 and 18. The noble Lord has reflected the debate in Committee, where we spoke at length about the challenges of the universal application of the super-affirmative procedure without further
refinement. I am pleased that we agree that there is an issue of proportionality as regards when these powers should apply. I commend his endeavour to make his drafting meet the intended purpose and thank him very much. He has drawn a distinction between what is defined in his amendment as “significant new” policy or significant change to policy, and the rest.
However, the noble Lord has combined Amendments 3, 28, 41 and 49 with Amendments 88 to 90. These remove all use of the draft affirmative procedure from the Bill where alternative procedural arrangements are not otherwise specified in Clause 45(3).
If these amendments were applied together, this would mean that there would be no alternative other than the super-affirmative procedure for the vast majority of the exercises of the powers under the Bill. In effect, all uses of the regulation-making powers, other than in relation to the setting of fees, or civil sanctions, or when in an emergency, would be subject to the super-affirmative because no procedure is specified in the noble Lord’s amendment for regulations that do not make significant policy changes. The distinction between the “significant policy” changes as he has suggested in Amendments 3, 28, 41 and 49 is therefore lost when they are combined with the other amendments in his name.
Before I address what this would mean in relation to emergencies, I will bring us back to the practical realities of what use of the super-affirmative procedure would involve. Significant amounts of legislation have yet to be made, where we know it has to be made, right across government. Indeed, it is likely that we have a very full year ahead of us. The former business managers among us know what that means in terms of process.
The super-affirmative procedure requires an additional layer of scrutiny to the draft affirmative. Parliament is given 30 days to consider a draft statutory instrument and present recommendations and representations. A final draft of the statutory instrument can then be formally laid to start its normal draft affirmative process only after that 30-day period has ended. All that could take significantly more than 30 days, since any period when Parliament is adjourned for more than four days is not taken into account in those 30 days. I also ask your Lordships: please remember that this super-affirmative process would be in addition to the existing assurances we have already built into the Bill.
Public consultation will apply to all regulatory changes other than in emergencies. Those consultations are those in which parliamentarians can themselves make comment—or indeed, parliamentary committees, if they feel so obliged. Parliament will be provided with a report every two years. That will allow it the opportunity to express itself, however it wishes to and on matters it wishes to, in relation to how the powers have been and may in future be exercised.
Since the Bill’s introduction, the majority of the exercises of the powers in the Bill were already subject to the draft affirmative procedure. We have since made changes to make that process near-universal, with the negative procedure now applying only to regulations about fees and regulations supplementing the enforcement regime for medical devices. We have also heard the
recommendations of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee, and have changed the use of the negative procedure to the “made affirmative” procedure when making emergency regulatory changes urgently where there is an imminent risk of serious harm to health.
We have listened. However, the noble Lord’s changes go considerably beyond the changes I made in Committee to meet him in the middle between the need for scrutiny and the need for practical legislation-drafting.
I understand that the noble Lord wishes to draw a line between what he might call a “minor” change to regulations and a “significant” change, which he thinks would be better dealt with through a higher level of parliamentary scrutiny such as the introduction of a new stand-alone medical devices regime. However, in attempting to make changes to the legislation to cater for the instances of significant policy, he draws everything else into the same unwieldy process, and does so when we have already sought to provide for the scrutiny and opportunity to influence that he seeks, in a more flexible way. If Parliament wants to take a view on legislative changes before they are made, it can, based on the amendments on public consultation already provided for in Committee. But it is not obliged to. That is our difference of opinion: that we should not be subject to an unduly restrictive process when the critical feature that the noble Lord wishes to see built into the Bill is not the timeframe, nor the specifics of the process, but a way of ensuring that there is an opportunity for Parliament to express a view at a point in time when the policy behind any changes is in development. That is already provided for.
The noble Lord has form in asking us to define terminology. He has presented us with a specificity without definition. It is unclear who would make the determination of what a “significant” policy change would be. Nor is it clear what “significant” would mean, and to whom. Indeed, how could we or anyone arrive at an objective test? Without such clarity, uncertainty would compel the application of the super-affirmative process, and we return to the difficulty of applying bulky procedure to matters where being deft and quick is essential. There is a real risk that the most urgent of changes would be ensnared by the super-affirmative procedure without a clear and unambiguous distinction on when the higher threshold must apply.
However, setting aside definitions of “significant”, removing the draft affirmative procedure from the Bill entirely would apply the super-affirmative without distinction. Let me give one example of what that would mean. It was necessary in December to make an urgent regulation to accommodate the coronavirus and influenza vaccination rollout, as we identified issues with the regulation. I do not think noble Lords would disagree that proactive regulation of that kind is helpful to all of us when it comes to an emergency situation. But even this would be subject to the super-affirmative procedure if the noble Lord’s amendment were to be carried.
It simply does not make sense to apply such a procedure when all the other safeguards in the Bill are in place to guarantee consultation, to ensure that views are heard and to ensure that Parliament can exercise its rights to be heard as freely as any other party.
I understand the arguments about parliamentary scrutiny. However, I strongly maintain that the Bill as amended in Committee strikes the right balance between effective challenge and scrutiny of our regulations, and is workable legislation. I hope the noble Lord has now received sufficient assurances, as well as understanding the challenges inherent in his proposed approach, and I hope that he will feel able to withdraw his amendment.